Last week, as the industry continued to wait for promised guidance from the U.S. Food and Drug Administration ("FDA") regarding its plan for regulating cannabis and cannabis-derived products, FDA issued a statement directed to consumers and 15 warning letters to CBD companies.
The consumer update, What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD, sketched a dotted line around what has been taking shape at the agency since the formation of an internal agency working group to explore possible pathways for CBD-containing dietary supplements and conventional foods to be marketed legally under the federal Food, Drug, and Cosmetic Act ("FDCA"). For those who attempt to read the proverbial tea leaves by following closely the statements made by FDA and its officials, the information in the update will sound familiar.
- Additional detail regarding safety concerns. The data that the agency has reviewed point to risks—(i) liver toxicity, (ii) potential for interactions with drugs or other ingredients (e.g., herbs) in dietary supplements, and (iii) possible male reproductive toxicity— that it cannot ignore and that may occur without consumer awareness. The agency noted that CBD may also cause other side effects more obvious to the consumer including changes in alertness and mood, as well as, gastrointestinal distress. FDA indicated that gaps remain in the safety data it has seen to date. It seems that the opportunity to answer FDA's call to "Collect Better Data" remains open.
- Specific unanswered questions. FDA expressed continued concerns about several unknowns—the results of cumulative exposure to CBD; the effect of CBD on special populations (e.g., children, elderly, pregnant or lactating women), and the safety of CBD for animals from pets to those that produce or become food for humans.
- Unfounded marketing claims. FDA has ongoing concern regarding human and animal products marketed with unproven efficacy claims and absent FDA's evaluation for safety concerns including appropriate dosing and side effects.
- Manufacturing quality concerns. Additional enumerated concerns included CBD content below labeled amounts and potentially unsafe levels of contaminants. Unsurprisingly, FDA did not acknowledge that a lack of regulatory standards is a likely contributing factor to such issues.
The consumer update concluded with an indirect update to industry:
- Reiterating FDA's continued belief that the best path forward for new drugs is the existing drug approval process.
- Acknowledging the existence of CBD-containing products marketed as food or dietary supplements and restating the agency's view that marketing these products is illegal.
- Suggesting that the information FDA has to date is insufficient to support a change to the existing regulatory framework and instead highlights the need for additional data regarding the safety and potential uses of CBD. Interestingly, in recent speeches, FDA has indicated a desired change to the regulatory framework for dietary supplements that would provide FDA with a way to more clearly and directly enforce against dietary supplements containing drug ingredients.
Ending with a commitment to "inform all stakeholders as quickly as possible" once the regulatory pathways become clear, FDA let the industry know that time is not now.
FDA's direct "guidance" to industry came in the form of 15 warning letters and an accompanying press release issued on the same day as the consumer update. The content of the release and warning letters were substantially similar to previously issued letters and statements with a few things worth noting below.
- CBD is not GRAS. One of the new insights provided by FDA's communications was an unequivocal statement regarding FDA's position that "it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food." If we accept FDA's position, conventional food with CBD would be adulterated unless, prior to marketing, CBD had FDA approval as a food additive. To date, FDA has relied primarily on the prohibition in section 301(ll) of the FDCA1 as the basis for its conclusion that CBD added to conventional food is unlawful. Even if someone could establish that CBD was marketed prior to being studied as part of "substantial clinical investigations" known to the public (e.g., Sativex, Epidiolex trials) , FDA's position stands as another obstacle to the lawful marketing of CBD in conventional food.
enforcement? Until now, the understanding has been that
under FDA's informal enforcement discretion policy FDA would
limit its enforcement to companies making egregious claims to treat
serious or life-threatening diseases. This week's
communications seem to solidify an expansion—first seen in
October warning letter—of the informal policy to include
products targeted at vulnerable populations.
Additionally, although one letter identified only a few problematic claims far from the type of claims identified in past letters, it was the only letter issued by the Center for Veterinary Medicine (CVM); whereas, the other fourteen letters were issued by the Center for Drug Evaluation and Research (CDER) and the Center for Food Safety and Applied Nutrition (CFSAN). Whether, this signals a meaningful expansion of enforcement or not remains to be seen.
- What FDA didn't
Despite calling out problematic product-specific claims as evidence that products that might otherwise be cosmetics were "drugs" under the FDCA, FDA did not consistently say that cosmetic products with CBD were unlawful. This was true even in instances where FDA relied on broad, non product-specific statements on a company's website or social media (e.g., blog post highlighting the benefits of CBD generally) as evidence that other products were "intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body." 21 U.S.C. §321(g) (Defining "drug."). However, based upon a review of the websites cited in the letters2 it is clear that FDA did not name every product with problematic claims. We should also remain cognizant of FDA's ubiquitous warning letter statement, "The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products."
Although, some parties presenting at the May public hearing voiced support for FDA's concern regarding the impact of making CBD widely available on commercial incentives to conduct clinical research, FDA was notably silent on this issue this time.
FDA has made clear that its approach to regulating CBD is the one applicable to any substance regulated by the agency. Thus, although the focus of FDA's most recent communications was CBD, unless FDA's much-anticipated actions create a broad alternative pathway for all cannabinoids, the same regulatory framework FDA is applying to CBD now will apply to all other cannabinoids, regardless of source. Accordingly, FDA's actions will likely strongly impact the medical and adult use cannabis markets eventually.
1 Under section 301(ll) it is a violation of the FDCA to introduce into interstate commerce a "food to which has been added a drug approved under section [505 of the FDCA] or . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless [an exception applies]." 21 U.S.C. § 331(ll).↩
We reviewed the company websites shortly after FDA issued the warning letters. As of November 27, 2019, some companies had already made changes to their websites.↩
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